Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Visual Analog Pain Scores
研究概览
简要总结
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
详细描述
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded and will not be informed if they received the study drug or not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease
- •Receives open, one-level posterior spinal fusion
排除标准
- •Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
- •Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and post-operative data will be excluded from the analysis for these patients.
- •Has severe liver disease. Bupivacaine is primarily metabolized in the liver via conjugation with glucuronic acid. Patients with liver disease, especially severe disease may be more susceptible to toxicity.
- •Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the kidneys. Excretion can be significantly changed by urinary perfusion, the presence of renal disease, factors affecting urinary pH, and renal blood flow
- •Is less than 18 years old.
- •Is pregnant.
- •Cannot read and speak English.
研究组 & 干预措施
Group A: Exparel
Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL).
Frequency: Single intraoperative administration
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Change in Visual Analog Pain Scores
时间窗: Through study completion, an average of 2.5 days
Change in Visual Analog Pain Scores over time; respondents report pain at incision site and at drain site on a scale of No pain (0) to Intolerable pain (10).
次要结局
- Total Opioid Consumption(Through study completion, an average of 2.5 days)
- Patient Cost of In-Hospital Stay(Through study completion, an average of 2.5 days)
- Discomfort(Through study completion, an average of 2.5 days)
- Length of Stay(Through study completion, an average of 2.5 days)
- Number of Participants with Pain(Through study completion, an average of 2.5 days)
- Number of Opioid-related Adverse Events(Through study completion, an average of 2.5 days)